Presentation on theme: "EU course on Environmental Exposure Scenarios in Risk Assessment"— Presentation transcript:
1EU course on Environmental Exposure Scenarios in Risk Assessment Assessment of environmental risks of biocides - focus on emission scenarios
2EU Regulations and Directives new chemicals EC Directive 67/548/EECexisting chemicals EC Council Reg. 793/93pesticides EC Directives 91/414/EECbiocides EC Directive 98/8/EECveterinary drugs EC Regulation 2377/90feed additives EC Directive 70/524/EECfood additives 89/107/EECcosmetics SCP/803/90packaging material EC Directive CS/PM/1025
3Elements of ‘Chemicals Control’ Data collection and exchange of informationClassification and labellingRisk assessmentRisk management (a.o. authorisation)
4The EU Biocidal Products Directive (1998) Why ? : Risk Management !Whereas 1: ‘ Council .. need for risk management of non-agricultural pesticides ..’How ? (1): Authorisation procedureWhereas 4: ‘.. rules for placing on the market .. taking as a condition a high level of protection for humans, animalsand the environment ..’How ? (2): Risk AssessmentWhereas 7, 8, 9, 11; Article 5; Annex VITGDs: data requirements, risk assessment of active substances, ...
11PNEC derivation (water) Data Assessment factorShort-term L(E)C50 from each of three trophic levels of 1000the base-set (fish, daphnia, algae)One long-term NOEC (either fish or Daphnia) 100Two long-term NOECs from species representing twotrophic levels (fish and/or Daphnia and/or algae)Long-term NOECs from at least three species representing 10three trophic levels (normally fish, Dapnia, algae)Field data or model ecosystems case by case
12EU TGD: importance of emission estimation The TGDs were to be revised, and to also incorporate aspects which are specific for risk assessment of biocidesFor biocides, the addition of specific emission and exposure scenarios had a high priority (Biocides TM, 1999)why ?uses are the most prominent difference with other chemicalsemission has most significant influence on the final outcome of risk assessment
13Experience of initial vs. refined RAs Uncertainty Factor__________________________________________PNEC ± 10emission rates > 1000STP emission estimation < 10biodegradation in surface water < 10exposure assessment PEC > 10,000
15Definition of ESD An Environmental Emission Scenario Document is: “A set of conditions about sources, pathways, production processes and use patterns that quantify the emissions (or releases) of a chemical from production, formulation, processing, private use (or use in the household) and recovery/disposal into water, air and solid waste”(OECD 2000)In general, an ESD should cover all aspects of the life-cycle. An ESD may cover only some parts of the life-cycle, if remaining parts are not relevant or covered by another ESD.
16Life Cycle & Risk Assessment New &ExistingSubstancesPRODUCTIONFORMULATIONAPPLICATIONSERVICE LIFEWASTEBiocidalProductsDirectiveLocal &RegionalScaleLocalScale
17Next stage of life cycle Local scale(1 point sourcefor each lifecycle stage)AIR100 mProcessNext stageof life cycleWastewaterSTPSOIL
18Regional scale Production P P (all sources all stages of l.c.) FormulationIndustrial useIIIPIIIFIIFFIIP
19Process Factors of Importance Industrial category Function of substancesProcessQuantity of productContent in productEmission factor(s)
20Concept of Emission Estimation Elements:Description of the industry or use area (‘process’)Description of the types of substances used and their function in the industry areaIdentification of points of release and emission factorsInformation on the scale/size of operationsInformation on emission control measuresInstruction on how to use the information in ESDand examples of calculations
21Emission Scenario 1: Tonnage of Substance INPUT:EF Emission factor (-)Tem Number of emission days (d.yr-1)Q Tonnage (tonnes.yr-1)Fms Fraction of the main source (-)Emission = Q * Fms * EF / Tem * 10-3 (kg.d-1)Main SourceTonnageWaterAirSoilWasteEmissionfactorsNo. of days
22Emission Scenario 2: Scale of Process INPUT:Qp Tonnage of product (tonnes.d-1)EF Emission factor (-)Qs Quantity of substance (kg.tonne-1 product)Emission = Qp * Qs * EF (kg.d-1)Emission Factor
23Emission Scenario 3: Average consumption INPUT:Qi Consumption per inhabitant (l.d-1)Cs Content of the substance in product (kg.l-1)Fpc Fraction of product with substance (-)EF Emission factor (-)Ni Number of inhabitants (-)Emission = Qi * Ni * Fpc * Cs * EF (kg.d-1)
24New & Existing substances Biocides A Biocide is a new or existing substancebuta new or existing substance is not (always) a biocideA Biocide has a specific function :DisinfectantPreservativeInsecticide, acaricide, avicide, piscicide, . . .
26EU Biocidal Products Directive 23 Product Types divided over 4 Groups:I DISINFECTANTS & GENERAL BIOCIDESII PRESERVATIVESIII PEST CONTROL PRODUCTSIV OTHER BIOCIDES
27I DISINFECTANTS & GENERAL BIOCIDES 1 Human hygiene biocidal products2 Private & public-health area disinfectants and other biocidal products3 Veterinary hygiene biocidal products4 Food and feeding area disinfectants5 Drinking water disinfectants
28II PRESERVATIVES 6 In-can preservatives 7 Film preservatives 8 Wood preservatives9 Fibre, leather, rubber and polymerised materials preservatives10 Masonry preservatives11 Preservatives for liquid cooling and processing systems12 Slimicides13 Metalworking-fluid preservatives
29III PEST CONTROL PRODUCTS 14 Rodenticides15 Avicides16 Molluscicides17 Piscicides18 Insecticides, acaricides & products to control other arthropod species19 Repellents and attractants
30IV OTHER BIOCIDES 20 Preservatives for food or feedstocks 21 Antifouling products22 Embalming and taxidermist fluids23 Control of other vertabrates
32Emission Scenarios of New & Existing Substances a) Tonnage Example 1 Pt 1 : Human Hygiene Biocidal ProductsEmission Scenarios of New & Existing Substancesa) Tonnageb) Average consumption per inhabitant
33Example 2 Pt 3 : Veterinary Hygiene Biocidal Products 3.1 Disinfection of animal housing3.2 Disinfection of footwear and animals’feet3.3 Disinfection of milk extraction systems3.4 Disinfection of means of transport3.5 Disinfection of hatcheries3.6 Disinfection of fishfarms
34“ ” “ ” Example 2 Disinfection of animal housing PRODUCTION FORMULATIONAPPLICATIONSERVICE LIFEWASTE“ ”“ ”
35Example 2 Disinfection of animal housing TimeNo. of cowsMoment ofmanuringMaximum per haN / P2O5
36The EUBEES projects EUBEES In 1999, a number of EU Member States, the European Chemicals Bureau and the European chemical industry (CEFIC), and supported by the European Commission, set up the EUBEES working group to develop environmental emission scenarios for environmental risk assessment of biocides in the framework of the Biocidal Products Directive.EUBEESEUBEES 1 project: January 2000 until June 2001EUBEES 2 project: January 2002 until November 2003
37EUBEES 1: Results (1)Report ‘Development of emission scenario documents for 23 product groups of the EU biocidal products directive 98/8/EG’, INFU/UBA, D.‘Emission scenario document for product type 2: private and public health area disinfectants and other biocidal products (sanitary and medical sector)’, RIVM, NL.‘Emission scenario document for biocides used in paper coating and finishing (product type 6,7&9)’, INERIS, F.‘Emission scenario document for biocides used as preservatives in the leather industry (product type 9)’, INERIS, F.
38EUBEES 1: Results (2)‘Emission scenario document for biocides used as preservatives in the textile processing industry (product type 9&18)’, INERIS, F.‘Emission scenario document for biocides used in taxidermist and embalming processes (product type 22)’, INERIS, F.Report ‘Proposal for the formats of names, parameters, variables, units and symbols to be used in emission scenario documents’ , RIVM, NL.
39EUBEES 2: objectives and results (1) 1 Development of harmonised ESDs:PT 11: preservatives liquid cooling & processingPT 12: slimicidesPT 13: metal working fluid preservatives[PT 21: antifouling products (in OECD)]2 Check ESDs for existing substances on their suitability for biocides:PT 1: human hygiene biocidal productsPT 6: in-can preservativesPT 7: film preservativesPT 9: fibre, leather, rubber, polymerised material pres.
40EUBEES 2: objectives and results (2) 3 Provide a framework for EU discussion and agreement of new ESDs developed by the members, eg.:PT 5: drinking water disinfectantsPT 10: masonry preservativesPT 14: rodenticidesPT 18: insecticides (in stables and manure)4 Test the scenarios for wood preservatives developed by OECD and rodenticides developed by the Nordics in the framework of EUBEES, primarily with regard to usability.
41OECD ESD on antifouling products Antifoulants: inhibit growth of organisms on ship hulls, fishing nets, marine structures. (several definitions!)Aim: OECD-wide harmonisation of available emission scenarios for anti-fouling applications.Most antifoulings, ie. 95% are used on ship hulls. Almost all available scenarios deal with the estimation of releases of antifoulings during the service life.The EESAF steering group will have its third meeting in November The draft ESD is intended to be finalised early 2004 and submitted to the OECD JM end 2004.
42ESDs for Main Group 1 (disinfectants) PT 01: Human hygiene biocidal products (RIVM, EUBEES2)PT 02: Private and public health area disinfectantsMedical equipment (EU)Accomodation (RIVM)Industrial areas Swimming pools (RIVM)Air-conditioning Chemical toilets Wastewater treatment (RIVM)Hospital waste
43ESDs for Main Group 1 (disinfectants) PT 03: Veterinary hygiene biocidal products () (RIVM)PT 04: Food and feed area disinfectants PT 05: Drinking water disinfectants ( ) (UBA EUBEES 2 CA)EUBEES
44ESDs for Main Group 2 (preservatives) PT 07: Film preservativesPaints & coatings (PT 06) Plastics (PT 09) Glues & adhesives (RIVM)Paper & cardboard (RIVM)PT 08: Wood preservatives (OECD)
45ESDs for Main Group 2 (preservatives) PT 09: Fibre, leather, rubber & polymer pres.Textiles & fabrics (EU)Leather & hides (EU)Paper & cardboard (EU)Rubber, polymers, etc. PT 10: Masonry preservatives () (EUBEES 2 CA)
46ESDs for Main Group 2 (preservatives) PT 11: Preservatives for liquid cooling & processing systemsCooling systems () (EUBEES 2 CA)Processing water & liquids PT 12: SlimicidesPaper & pulp () (EUBEES 2 TM)Mineral oil extraction () (EUBEES 2 TM)PT 13: Metalworking-fluid preservatives () (EUBEES 2 CA)
48ESDs for Main Group 3 (pest control) PT 18: Insecticides, acaricides and products to control other arthropodsManure & stables () (RIVM)Refuse dumps Fumigants (RIVM)PT 19: Repellents and attractants
49ESDs for Main Group 4 (other products) PT 20: Preservatives for food & feedstocks PT 21: Antifouling products () ongoingPT 22: Embalming and taxidermist fluids (EU)PT 23: Control of other vertebrates
50EU Risk Assessment TGD new version Harmonised Approach to Risk Assessment ofNew Chem, Existing Chem and BiocidesHarmonised Approach to Risk Assessment in theMarine Environment (N.E.B. and OSPAR)Include in Guidance what has been learned in theExisting and New Chemicals areasInclude specific guidance for Biocides(i.e. emission scenarios!)Reducing discussion time and disagreementsthrough increasing the extent of guidance> documents
51Revised TGD (2003): relevant exposure assessment issues More complete life cycle assessmentRelease estimationemissions from long-life articlesemissions from waste disposal including recoveryUnintentional uses: calculation of background concentrations
52Nice questions! (1)Should the waste stage be included in the exposure assessment of biocides?Yes, the BPD in principle covers also waste stageHowever the TGD (2003) and the OECD PT8 ESD do not contain models to quantify emissions from waste stage. Relevant assumptions would include (wood preservatives):how much wood enters the waste stagehow much of that goes to landfill, resp. incinerationhow much of the a.i. is still left in the woodetc..
53Nice questions! (2)How to use the new (TGD) long-life article emission scenario for wood preservatives and what is the relation to the OECD wood in service scenario?The TGD approach deals with constant emissions over a long time and relates to the regional scale.The OECD scenarios should be followed for wood preservatives. The scenario for wood in service has a different approach. The TGD scenario does not apply for wood preservatives.
54Nice questions! (3)How should background concentrations and PEC regional be calculated for biocides? Which releases should be taken into account?Biocides emissions generally pertain to local emissions and result in calculations of PEC local.Background concentrations and PEC regional can therefore normally not be determined.